Brush Buddies®

SPL v1

SPL

SPL Set ID b3006c29-1f7f-4d9f-ab46-5a36df1a0471

Route

DENTAL

Published

Effective Date 2025-01-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.221 g)

Inactive Ingredients

Sorbitol Water Hydrated Silica Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Fd&c Blue No. 1 Fd&c Yellow No. 5 D&c Red No. 30 Phthalocyanine Blue Mica Titanium Dioxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-31

Description

Sodium Fluoride 0.221% w/w (Fluoride ion content 1000 ppm)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Fluoride 0.221% w/w (Fluoride ion content 1000 ppm)

Uses

helps protect against cavities.

Section 42229-5

HELPS PREVENT CAVITIES

COLOR CHANGING GREEN TO PURPLE

make brushing fun!^®

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS. NOT TESTED ON ANIMALS.

EC No. GUJ/COS/GC-679

OFFICIAL LICENSED PRODUCT

DESIGNED IN U.S.A. • MADE IN INDIA

QUALITY GUARANTEE

Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST

ABOUT US

Crayola A Hallmark Company

©2025 CRAYOLA, EASTON, PA 18044-0431.

Crayola™, and Serpentine Design™ are trademarks of Crayola used under license.

Toothpaste changes color from GREEN. to PURPLE, indicating effective brushing.
Encourages children to brush for 2 minutes.
Helps maintain a bright smile and a healthy mouth.

Section 50565-1

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Packaging

Directions

• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

• Do not swallow.

• Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

• Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient

Sodium Fluoride 0.221% w/w

(Fluoride ion content 1000 ppm)

Inactive Ingredients

Sorbitol, Aqua, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Blue 1, Yellow 5, Red 30, Blue 15, Mica, Titanium Dioxide

Questions Or Comments?

Call toll free 1-877-274-8358

Structured Label Content

Uses

helps protect against cavities.

Section 42229-5 (42229-5)

HELPS PREVENT CAVITIES

COLOR CHANGING GREEN TO PURPLE

make brushing fun!^®

CAUTION:

AVOID EXCESSIVE INGESTION.

NOT FOR PETS. NOT TESTED ON ANIMALS.

EC No. GUJ/COS/GC-679

OFFICIAL LICENSED PRODUCT

DESIGNED IN U.S.A. • MADE IN INDIA

QUALITY GUARANTEE

Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST

ABOUT US

Crayola A Hallmark Company

©2025 CRAYOLA, EASTON, PA 18044-0431.

Crayola™, and Serpentine Design™ are trademarks of Crayola used under license.

Toothpaste changes color from GREEN. to PURPLE, indicating effective brushing.
Encourages children to brush for 2 minutes.
Helps maintain a bright smile and a healthy mouth.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Purpose

Anticavity

Packaging

Directions

• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.

• Do not swallow.

• Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.

• Children under 2 years of age: Consult a dentist or doctor.

Drug Facts

Active Ingredient (Active ingredient)

Sodium Fluoride 0.221% w/w

(Fluoride ion content 1000 ppm)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Aqua, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Blue 1, Yellow 5, Red 30, Blue 15, Mica, Titanium Dioxide

Questions Or Comments? (Questions or comments?)

Call toll free 1-877-274-8358

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "helps protect against cavities.", "42229-5": "HELPS PREVENT CAVITIES COLOR CHANGING GREEN TO PURPLE make brushing fun! ® CAUTION: AVOID EXCESSIVE INGESTION. NOT FOR PETS. NOT TESTED ON ANIMALS. EC No. GUJ/COS/GC-679 OFFICIAL LICENSED PRODUCT DESIGNED IN U.S.A. • MADE IN INDIA QUALITY GUARANTEE Ashtel Studios Inc. guarantees the quality of this Crayola product. If this product does not perform properly, please contact us at 1-877-274-8358, Monday - Friday 8AM - 5PM. PST ABOUT US Crayola A Hallmark Company ©2025 CRAYOLA, EASTON, PA 18044-0431. Crayola™, and Serpentine Design™ are trademarks of Crayola used under license. Toothpaste changes color from GREEN. to PURPLE, indicating effective brushing. Encourages children to brush for 2 minutes. Helps maintain a bright smile and a healthy mouth.", "50565-1": "Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.", "Purpose": "Anticavity", "Directions": "• Adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • Do not swallow. • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. • Children under 2 years of age: Consult a dentist or doctor.", "Active ingredient": "Sodium Fluoride 0.221% w/w (Fluoride ion content 1000 ppm)", "Inactive ingredients": "Sorbitol, Aqua, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Saccharin, Blue 1, Yellow 5, Red 30, Blue 15, Mica, Titanium Dioxide", "Questions or comments?": "Call toll free 1-877-274-8358"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:14.415019 · Updated: 2026-03-14T23:06:44.003626